Flexible License Plans
Tailored to your organisation
SMART-TRIALeCRF For clinical investigations, pre- or post-market
- eCRF & visit events
- AE/SAE module
- Medication module
- Monitoring features
- Email & telephone support
SMART-TRIALSuite The best of both, eCRF and ePRO together in one Popular
- All eCRF features
- All ePRO features
- Combined study flow
- Automatic triggers
- Email & telephone support
SMART-TRIALePRO Collect data directly from subjects
- ePRO & subject events
- Email questionnaires
- SMS questionnaires
- Email & telephone support
Your insurance for success
Our customer success team will help you take the first step in using the platform. From there on, you can setup and manage studies in SMART-TRIAL all by yourself.
User Onboarding is mandatory for all licenses and includes consultancy and help with study set-up to minimise the time of implementation.See our references »
- Hands-on workshop
- Form design feedback
- Protocol design feedback
- Hands-on help with first setup
- Data management training
The only EDC platform tailored for medical devices
EU MDR Compliance
Designed to support your continuous clinical evaluation process.
Intuitive Study Builder
Reduce the set up time with a 4-step "do it yourself" study builder.
No limits on the no. of users, sites, processes, forms, or subjects.
What some of our Clients Have to Say
- “ SMART-TRIAL will enable our many clinical specialists to better collaborate, interact and speed the collection of clinical evidence. ”
Sofia JonhedeOticon Medical AB, Sweden
- “ ElMindA is a data-driven company and constantly aims to improve the quality and visibility of data. We believe that the SMART-TRIAL data management platform will help us to achieve these mandatory goals.”
Liran KorineElMindA, Israel
- “Oticon's mission is to continue delivering the best hearing aids in the world. And we believe that SMART-TRIAL can help us doing this faster than we have done before.”
Karen Elise Karlsmose BoelOticon A/S, Denmark
- “SMART-TRIAL’s disruptive cloud technology helps Quanta’s clinical trial teams to work faster and significantly reduce the costs of generating and managing clinical and operational data, from our perspective, it is transforming our extended data ecosystem.”
James GraingerQuanta Dialysis Technologies, England
- “With SMART-TRIAL we have the opportunity to collect and manage our post-market data from all over the world in one place. The email and SMS reminders help with the timeliness of responses and, after a study ends, the data can straightforwardly be downloaded. Whenever we are in doubt about anything, support is friendly, efficient, and fast.”
Laura Winther BallingWidex A/S, Denmark
- “Due to the sensitive topic and the large target size, we had high demands on both security and usability. We believe we made the right decision by selecting SMART-TRIAL, because it meets our requirements for both compliance and a user-friendly interface.”
Unnur A. ValdimarsdóttirÁfallasaga Kvenna- SAGA cohort
- “ With SMART-TRIAL I manage to collect higher quality data in less time for all sizes of multi-site trials, without having to worry about security or compliance.”
Dr. Lise TarnowNordsjælland Hospital Research, Denmark
- “ SMART-TRIAL has given us more opportunities in a user friendly way to manage our data collection in our testing and research projects with our customers and end-users.”
Kristleifur KristjánssonÖssur - global leaders in non-invasive orthopaedics, Iceland
Frequently Asked Questions
- Why is onboarding required?
The SMART-TRIAL services and technology are both new and different compared to what you might be used to. To ensure that you get the most out of the platform, an onboarding program is required to ensure a successful start. This includes training and consultation in setup, planning, eCRF and process design, and help with set-up of your first studies in SMART-TRIAL. Contact us to learn how you can gain the most value from our User Onboarding.
- How do I install or set up SMART-TRIAL?
SMART-TRIAL is a web-based software as a service (SaaS) solution that requires no specific implementation or installation. SMART-TRIAL is accessible in most modern browsers and is built on modern technology that makes it possible to access on most devices through an internet browser.
- How do you set up or build a study in SMART-TRIAL?
SMART-TRIAL is a “do it yourself” solution. This means that after you’ve completed onboarding, you can setup everything by yourself – it doesn’t require any programming knowledge. You can use the ready-to-use modules to set up your study for eCRF, ePRO, or both. Create forms, processes, and sites, by using a drag-and-drop interface.
- How does archiving of data work?
With SMART-TRIAL you can choose to archive your study if you don’t need to collect data anymore. That is, you can keep all your study data safely stored in one place for as long as you wish. When your study is archived, you can only export data and review your setup, but you don’t have to pay any license fees. Please note: archiving is not for free if you require more than 1GB storage. You will have to continue paying for your data hosting. Contact us for further pricing enquiries.
- Can I migrate existing data or system to SMART-TRIAL?
Yes, we do provide a service to migrate older data to SMART-TRIAL. However, it's highly dependent upon the format, type of previous storage, access to data, etc. Contact us and we’ll see what we can do.
- How's security & quality handled in SMART-TRIAL?
SMART-TRIAL is designed and developed according the IEC62304 and ISO13485 quality standards and hosted in a secure environment that’s supported by Microsoft Azure. We have a complete set of SOPs and tools to ensure both stable work environment, and secure data storage. Read more about the security & quality' and take a look at the Security & Service Statement, and the GCP, HIPAA, CFR21 statement.
- What’s included in a license?
There's no limit on the number of users, sites, processes, forms, or subjects. For all SMART-TRIAL licenses we include both email and telephone support, all mandatory software updates and any additional updates to the software, along with continuous backups and 99,95% promised uptime and availability.
- What's included in a SMART-TRIAL eCRF license?
The SMART-TRIAL eCRF license gives you access to eCRF feature (visit events), where users can log in and enter data into an electronic case report form. You also get access to clinical trial features like queries, the AE/SAE module, medication log (for concomitant medications and/or IMP) module, and medication accounting module.
- What’s included in a SMART-TRIAL ePRO license?
SMART-TRIAL ePRO/Survey license gives you access to ePRO/Survey (subject events), where you can send questionnaires to subjects via e-mail and SMS, create a survey, or combine both in a long-term process. 1.000 standard length (128 Alphanumeric characters) SMS are included every month. You can buy more SMS if you need.
- How does billing work?
Single-study licenses are always presented as a price per study per month. All licenses, with any additional modules, are billed up front for the upcoming month, or beforehand for the total number of months required. SMART-TRIAL multi-volume license packages are billed up front for the upcoming 12 months.
- How does support work?
All licenses include email and telephone support. Support is provided for all SMART-TRIAL users, from sponsor, monitors, to all site(s) staff (investigators etc.) – but not patients/subjects. Standard service hours are from 9.00 to 17.00 Monday through Friday and Sunday from 12.00 to 16.00 (CET Copenhagen).